The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-05

Study Completion Date

2025-07-05

Brief Summary

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This study is being conducted to determine the effect of EMLA cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.

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Detailed Description

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A chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. Chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. For this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. Chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. Therefore, chest tube removal is a painful, anxious and frightening experience for the patient. There are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. However, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.

Conditions

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Chest Tube Removal Children Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to experimental and control groups using block randomization method. Age, sex and procedural fear variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X3X2) and 24 children will be included in each group.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Using the block randomization technique, participants will be divided into 3 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B and C using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each child is in just before the application (researcher blinding).

Research data will be entered into the computer database by coding the group name as A, B and C, and statistical analysis will be performed using this coding (statistician blinding).

Study Groups

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Control

The chest tube removal procedure will be performed according to clinical routine practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

EMLA cream

EMLA cream will be applied to the chest tube area 3 hours before the chest tube removal procedure. Then, the chest tube removal procedure will be performed.

Group Type EXPERIMENTAL

EMLA Cream

Intervention Type DRUG

EMLA cream is applied once, 3 hours before the tube is removed. EMLA cream will be applied by the researcher in a thin layer to an area of 7-10 cm2, with the chest tube entrance to the skin remaining in the center. It will be covered with a Tegaderm transparent film dressing.

Cold application

Before the chest tube removal procedure, an ice cube pack will be applied to the chest tube area. Cold application will continue until the skin temperature drops to 13.0 degrees. Then the chest tube removal procedure will be performed.

Group Type EXPERIMENTAL

Cold application

Intervention Type PROCEDURE

Cold application will be made with an ice cube pack immediately before the chest tube removal procedure. Cold application will be applied to a 7 cm diameter area, with the chest tube entrance to the skin being considered as the center. Skin temperature will be measured with an infrared thermometer and will be ensured to reach 13.0 degrees. Ice pack application is expected to last approximately 9-10 minutes.

Interventions

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EMLA Cream

EMLA cream is applied once, 3 hours before the tube is removed. EMLA cream will be applied by the researcher in a thin layer to an area of 7-10 cm2, with the chest tube entrance to the skin remaining in the center. It will be covered with a Tegaderm transparent film dressing.

Intervention Type DRUG

Cold application

Cold application will be made with an ice cube pack immediately before the chest tube removal procedure. Cold application will be applied to a 7 cm diameter area, with the chest tube entrance to the skin being considered as the center. Skin temperature will be measured with an infrared thermometer and will be ensured to reach 13.0 degrees. Ice pack application is expected to last approximately 9-10 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Having two chest tubes (mediastinal/pleural) placed after open heart surgery
* Turkish literate
* With stable vital signs
* Willing to participate in the research

Exclusion Criteria

* Experience with chest tube removal procedure
* Using analgesics other than routine procedures before the procedure
* Children receiving mechanical ventilation support
* Children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.)
* Children with a mental disability, perception problem, visual and hearing impairment
* Children with communication problems. • Children with cold allergies

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No